South College
|Complete this form to request inclusion of procedures involving radiation (e.g., x-rays, CT scans, fluoroscopy, nuclear medicine studies, etc.) in the proposed |
|research. |
|Include only those exams/procedures that are to be administered for research purposes (i.e., not being performed as standard medical care). |
|The Human Subject Radiation Committee (HSRC) provides review of proposed research uses of radiation. Contact OSPR for more information on the procedure for |
|obtaining this review. |
|Radiation doses for most routine studies (including fluoroscopy or CTs of the chest, abdomen, or pelvis) may be obtained from the Duke University dose |
|calculator. These calculations of effective doses are approximations. Values obtained from the calculator may require adjustment during HSRC review to more |
|accurately reflect the procedures performed at South College. For procedures not listed or for other assistance contact OSPR. |
|Additional resources are available at RADAR Medical Procedure Radiation Dose Calculator and Consent Language Generator and Effective Doses in Radiology and |
|Diagnostic Nuclear Medicine: A Catalog. |
|Include the radiation risk language generated by using the dose calculator on applicable consent, assent, and/or parental permission forms prior to review. |
PI Name:
|Provide the location where the radiologic procedure(s) will be performed: |
| | |
|Name of Institution/Department Administering Procedure(s) |Address (street, city and state, or country) |
| | |
| | |
| |
|Specify the age(s) of participants who will receive radiation exposure. |
| |
| |
|Provide the total number of participants (receiving radiation exposure) for whom you are seeking approval. |
| |
| |
|Specify the participant population(s) to be included (check all that apply): |
| | |Children |
| | |Healthy volunteers |
| | |Pregnant women ( Provide an estimate of the radiation exposure to the fetus: |
| | |Women of childbearing potential |
| | |Other(s) not listed above – specify: |
|Indicate the type of pregnancy testing that will be used to exclude pregnant women. |
|A serum pregnancy test must be used if the study involves greater than 100 mrem or the ovaries are in the radiation field. |
| | |Serum BHCG test |
| | | Other pregnancy testing ( Specify and provide justification: |
| | |
| | |
|Indicate the type of HSRC review requested for this research: |
| | |Administrative |
| | |Protocols involving effective doses of 100 mrem or less – except in children, pregnant women, or healthy volunteers |
| | |Expedited (Subcommittee) |
| | |Protocols involving effective doses greater than 100 mrem but not greater than 3000 mrem (3 Rem) – except in children, pregnant women or healthy |
| | |volunteers; and protocols involving effective doses of 100 mrem or less in healthy volunteers |
| | |Full (Convened) Committee |
| | |Protocols involving children, pregnant women, or healthy volunteers receiving greater than 100 mrem; and protocols involving effective doses |
| | |greater than 3000 mrem (3 Rem) for all other populations |
| |
|Describe exams/procedures involving radiation and justification for each exposure. Indicate for each research participant the number of procedures administered |
|per year and the total number of procedures for all years of the participant’s exposure. |
|Include only exams/procedures that are administered for research purposes (i.e., not being performed as standard medical care). |
|Exam/Procedure(s) |Justification for Radiation Exposure |Number of |Total Number of |
| | |Procedures/Year |Procedures/Participant |
| | | | |
| | | | |
| |
|Complete a through d below to describe the radiation dose administered to participants for research purposes. Attach a copy of dose calculations (i.e., |
|printout from online dose calculator, including recommended consent language). |
|NOTE: 100 mrem = 1 mSv |
| |Nuclear Medicine Procedures Per Year | NA | |
| |Physician responsible for administration of nuclear medicine procedures: | | |
| |Radionuclide and chemical form: | | |
| |Name/description of procedure: | | |
| |Activity per administration (Bq, mCi): | | |
| |Maximum number of administrations per participant per year: | | |
| |Effective dose (mrem or mSv): | | |
| |X-ray Procedures Per Year | NA | |
| |For DEXA scans, specify unit (Lunar DPX-L, Lunar EXPERT, or Lunar PRODIGY) and type of scan (bone density or whole body composition). |
| |Name/description of procedure: | | |
| |Effective dose (mrem or mSv): | | |
| |Total Effective Dose Per Year (Sum of all nuclear medicine and x-ray procedures for research purposes per year) |
| |Effective dose (mrem or mSv): | | |
| |Total Effective Dose for All Years of the Study (Sum of all procedures performed for research purposes for all years) |
| |Effective dose (mrem or mSv): | | |
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